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FDA 510(k) Application Details - K161734
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K161734
Device Name
Unit, Operative Dental
Applicant
RITTER CONCEPT GMBH
BAHNHOFSTRABE 65
ZWONITZ 208297 DE
Other 510(k) Applications for this Company
Contact
WEN FANG
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/23/2016
Decision Date
12/09/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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